Ibrexafungerp

Common name: Ibrexafungerp

Trade name: BREXAFEMME

All names: BREXAFEMME, Ibrexafungerp, Irefungin

Indications:

BREXAFEMME is a triterpenoid antifungal drug indicated for the treatment of adult and postmenarche pediatric women with vulvovaginal candidiasis (VVC).

Usage and Dosage:

The recommended dose of BREXAFEMME for adults and postmenarche pediatric women is 300 mg (two 150 mg tablets) twice daily for one day, for a total therapeutic dose of 600 mg.

BREXAFEMME can be taken with or without food.

Before starting treatment, confirm whether a female of reproductive potential is pregnant.

Adverse Reactions:

The most common adverse reactions (≥ 2%) reported with BREXAFEMME in clinical trials for the treatment of vulvovaginal candidiasis were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

Contraindications:

Pregnancy

Allergy to Ibrexafungerp

Precautions:

Risk of Fetal Toxicity: Based on animal studies, harm to the fetus may occur. Inform females of reproductive potential to use effective contraception during treatment.

Concomitant use of strong CYP3A inhibitors may increase ibrexafungerp exposure. Reduce the BREXAFEMME dose and concurrently use a strong CYP3A inhibitor at 150 mg twice daily.

Concomitant use of strong and moderate CYP3A inducers can significantly reduce ibrexafungerp exposure.

Avoid coadministration of BREXAFEMME with strong or moderate CYP3A inducers.

Storage:

Store BREXAFEMME tablets at 20°C to 25°C (68°F to 77°F). Allow brief exposure to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Mechanism of action:

Ibrexafungerp is a novel glucan synthase inhibitor that combines the promising activity of a glucan synthase inhibitor with the potential flexibility of oral and intravenous delivery and is expected to be widely used in both inpatient and outpatient settings.

Safety and Efficacy:

The Phase III VANISH-306 study investigated the efficacy and safety of oral ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC). The results showed that ibrexafungerp was highly statistically superior, safe and well-tolerated compared to placebo in terms of the primary endpoint and key secondary endpoints. The study's positive results are consistent with the previously reported Phase III VANISH-303 study. The primary endpoint and key secondary endpoints in these two VANISH pivotal trials are required for regulatory approval of the VVC indication, and the study data paves the way for the submission of regulatory application documents for ibrexafungerp to treat VVC in the second half of 2020.